Addressing pharmaceutical counterfeiting and compliance with the Falsified Medicines Directive

The World Health Organization (WHO) has estimated that up to 10% of medicines across the globe are counterfeits. It can involve large scale manufacturing and affects every country. Not only does this situation cause a huge profit loss to the pharmaceutical industry, but it also poses dangers to the people taking these counterfeit medicines.

The level of counterfeiting across the pharmaceutical industry is continuing to grow for a multitude of reasons, including the increasingly complex nature of supply chains, the expansion of e-commerce and lack of enforcement capacity. Traceability and supply chain transparency have been longstanding requirements in the automotive and food industries. With a dramatic global increase of counterfeits in industrial and consumer goods, various regulations have been established in order to protect the legal supply chain. While the rate of pharmaceutical counterfeiting is not particularly high in Western countries, we are seeing regulations coming in to help identify, track and trace. The regulatory landscape is dominated by two forthcoming developments: the latest stops on the road to full implementation are the Falsified Medicines Directive (FMD) in Europe and the US FDA’s Unique Device Identification (UDI) system. Both pieces of legislation focus on serialization, now a matter of urgency for suppliers.

Defeating the counterfeiters demands a multilevel approach, an element of which is secure packaging. In Europe, FMD means new harmonized, pan-European measures including obligatory safety features on the outer packaging of the medicines – to carry a unique serial number to identify and authenticate individual products, and to be sealed in a way that visibly enables tamper verification. Not only can this growth in counterfeit medicines be extremely dangerous to patients, but also harmful to the brand owners that manufacture the legitimate product. Clearly, patients are likely to lose confidence in a brand if it is widely counterfeited.

Labels and packaging are helping the pharmaceutical industry meet ever-more complex legislative and compliance requirements for serialization, as governments around the world take to safeguard the health of consumers. In order to ensure optimal security of pharmaceutical packaging, both overt and covert technologies need to be used. A key aspect to the Falsified Medicines Directive is the requirement for tamper verification, which provides a visual indication of whether packaging has been opened or altered since the product was packed and shipped from the manufacturer. Tamper verification can be addressed through a variety of different methods. However, one of the most effective is the use of tamper verification labels, which are popular due to their versatility, to be applied to multiple packaging types and formats, ease of use and ability to carry branded information to the consumer.

Falsified Medicines Directive FMD Richtlinie FMD irányelv Directiva Europeană a Medicamentelor Contrafăcute

When choosing a tamper verification label, manufacturers should consider the consumer experience with the product and how it will be impacted by the application and use of the label. Tamper-evident labels can be provided with a variety of different features, which help consumers engage with the label and the brand. These labels are available with varying levels of sophistication. At every level, straightforward fiber-tear labels use a permanent adhesive that, when removed, irreversibly damages both the print and the board of the carton to which it is fixed. However from a consumer’s perspective, the removal of the label may leave behind unsightly remnants on the packaging, to the point where some may not want to use the same box to store any remaining medication. As a result, consumers may be left with a negative impression of the brand rather than appreciate the tamper verification that has been provided.

We place great value on the safety of our customer’s products while also ensuring a user-friendly solution for their end-consumers. That’s the main reason why we developed our FMD compliant patent-pending tamper-evident security seal for the protection of pharmaceutical product packaging. The cost-effective ELTRONIS seal is extremely reliable due to its simple, yet practical construction. For example, adding a non-adhesive tab helps consumers to easily open the seal and gain access in the intended way, reinforcing the product’s safety. The detachable latch, which can only tear along the predefined line, does not in any way damage the packaging, allowing the end-customer to reuse the medicine box. Tamper-evidence isn’t neglected in favor of user-friendliness. Our security seal incorporates security cuts, which make any sign of tampering easily noticeable, while also preventing the seal being reused.

It can be produced using transparent materials, which in turn doesn’t affect the design of the packaging, sparing you from a design change, which might not make the product instantly recognizable in the eyes of the regular customers. The dimension and color of the seal is variable on request, its shape not affecting its functionality. Size adjustments can also be made to include more information. Furthermore you can involve your costumers in the authentication process of your product through a hidden code and customized application. This allows consumers to personally confirm that the contents are authentic, which reinforces your brand’s legitimacy. Last, but not least, we have also incorporated tactile signs for visually impaired end-users.

The FMD introduced safety features must be placed on the packaging of most prescription and certain non-prescription medicines no later than February 9th 2019. These safety features will guarantee medicine authenticity for the benefit of both patients and businesses, and will strengthen the security of the medicine supply chain, from manufacturers to distributors, pharmacies and hospitals. Pfizer has already started protecting its products with our tamper-evident labeling solution.

Falsified Medicines Directive FMD Richtlinie FMD irányelv Directiva Europeană a Medicamentelor Contrafăcute

For more details on our company please visit our website or contact us directly. In case you would like to sample our Falsified Medicines Directive compliant patent-pending tamper-evident security solution and other pharmaceutical applications, you can also come by the ELTRONIS booth (G53) at this year’s Pharmapack Europe event. To register as a visitor for the event, all you have to do is access the following link. In case you can’t make to the event, you can request a sample pack anytime.